Since 2005, the FDA only accepts submissions of annotated ECG waveform data in electronic format (XML). This stipulation complies with the Health Level Seven (HL7) Annotated ECG Waveform Data Standard (aECG) accredited by the American National Standards Institute. Additionally the HL7 aECG standard format requires that a number of fields be present in the aECG files submitted to the FDA ECG Warehouse (see document "Beyond the Schema" ) .

More recently the FDA also encouraged Sponsors to submit to the FDA ECG Warehouse the continuous ECG recordings (aka Holters) used to extract the aECG (10 second resting ECG files) when available. These files must be compliant with the ISHNE Holter file format (see document "The ISHNE Holter Standard Output File Format").

AMPS provides a service to verify the conformity with the HL7 XML standards, including the additional FDA requirements, for both the resting and the continuous recordings. AMPS guarantees the files to be submitted, once verified, and if need be corrected, and will not be rejected by the FDA Warehouse at the time of the submission. This guaranteed service is an ideal solution for Core Labs and Sponsors that need to rapidly and efficiently verify large number of ECGs before the submission to the FDA Warehouse. After the file verification AMPS can also submit the files directly to the FDA ECG Warehouse.

How to use the service

AMPS accepts input annotated ECG XML files and continuous recordings deemed to be ready for submission to the FDA Warehouse. If you have ECG files not already in the standard FDA XML file format we can still help you prepare for submission. Please refer to the AMPS File conversion Service page on this web site.

As output AMPS can provide verified aECG XML files guaranteed to pass the FDA Warehouse validation at the time of submission.

Demographic information

To be compliant with the FDA HL7 XML format the following demographic information must be included in each submitted XML file:

• Study Identifier (Protocol ID)
• Site ID
• Subject ID
• Date and Time of the Recording

Should these fields not be present in your input files, AMPS can insert into the HL7 XML files annotations and demographic information when available. To minimize the risk of mistakes, the demographic data must be created in an individual Excel spreadsheet file for each study (or group of images uploaded) by the Sponsor/CRO.

Filename convention

Submitted files with defined file names and definitions must be made available to AMPS. Each study can have a different naming convention, chosen by the Sponsor/CRO. AMPS recommends the following file name: DateTime.StudyIdentifier.SiteID.SubjectID.VisitID

Data Transmission and storage

Digital data will be delivered to AMPS via upload to the secure AMPS FTP server.

After upload the images are automatically stored in a dedicated folder on the AMPS Customer Data Repository server. The Customer Data Repository is a password protected electronic repository that ensures only authorized personnel have access its content. The use of multiple disks guarantees data redundancy and allows data reconciliation in case of a single disk failure.

Intermediate and final results are saved in Read-Only mode. This ensures the results are not inadvertently altered or deleted. Date & time of file-creation, and the Identification of the AMPS personnel who generated the file will be available.

Processed Data Delivery

Delivery of generated HL7 XML files to the Sponsor/CRO can be made to a dedicated server, or by courier using any digital media such as DVD, solid memory/USB, etc. Alternatively, they can be submitted directly to the FDA ECG Warehouse, depending on the Sponsor/CRO request.

Price list

Verified aECGs:

Verified continuous recordings:

FDA ECG Warehouse submission aECGs:

FDA ECG Warehouse submission continuous recordings:

For quantities over 600 ECGs, further information, or questions please contact: AMPS.Services@amps-llc.com